Sanofi, Roche to increase access to clinical trial
data

Sanofi said Thursday that it will expand access to clinical trial information and data in support of commitments jointly issued in July 2013 by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Sanofi CEO Christopher A. Viehbacher noted that "finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers."

Viehbacher, who is also serving president of EFPIA, added that "data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers." Under the plan, Sanofi said that starting in January, the company will allow access to clinical trial data and related documents, including clinical study reports (CSR), for all studies, regardless of the outcome. "The private sector has taken a lead on this which I would hope academic researchers will follow," Viehbacher commented.

Specifically, Sanofi noted that the clinical studies must have been submitted to US and EU regulatory agencies and the product must have been approved by both agencies on or after January 1, 2014. Meanwhile, for the company's Sanofi Pasteur vaccine unit, requested studies must have been submitted either to US or EU regulatory agencies and the product must have been approved by either agency on or after January 1, 2014. Sanofi indicated that requests and access will be made through a portal for clinical trial data sharing that is also being used by Boehringer Ingelheim, GlaxoSmithKline and ViiV Healthcare.

Separately, Roche announced Thursday that researchers may now request access to patient-level data from the drugmaker's clinical trials through the same system. Since June 2013, Roche has provided access to CSRs and other summary reports under a pledge to broaden transparency around clinical trial data. Michael Doherty, the company's global head of regulatory affairs, remarked "we worked hard to develop an approach that strikes a balance between our commitment to sharing data from our trials, while safeguarding patient confidentiality and the regulatory process." Doherty added "we are enthusiastic about...the benefits greater openness could ultimately deliver to patients."

According to Roche, scientists may obtain access to patient-level data after requests have been reviewed and approved by an independent review panel on the "basis of scientific merit." The company said that data will be available for clinical trials that have been submitted together with an application for a medicine’s registration and will be available after the completion of regulatory reviews in the US and the EU, as well as for terminated programmes.

In 2012, GlaxoSmithKline announced that it would allow greater access to its clinical trial data to external researchers, the first major pharmaceutical company to do so. More recently, Pfizer said that it will expand access to clinical trial information to independent researchers and patients who take part in the studies. The moves come as the European Medicines Agency proposes to proactively make trial data available to researchers once an approval decision has been made.